Humeral FracturesPhase 1NCT02733666
Internal Fixation of Lateral Humeral Condyle Fractures With Absorbable Screws in Children
A Phase 1 study testing Absorbable screw group in people with Humeral Fractures, run by Children's Hospital of Chongqing Medical University.
Trial summary
Lateral humeral condyle fractures are the second most common elbow fractures in children. Displaced and rotated fractures require stabilization and reduction. Kirschner wires (K-wires) are most commonly used for fracture fixation. Here, the investigators introduce a new fixation method involving absorbable screws. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Humeral Fractures
- What is being tested?
- Absorbable screw group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All participants had been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III
Who cannot join
- participants had not been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III
About this study
Official title: Open Reduction and Internal Fixation of Lateral Humeral Condyle Fractures With Absorbable Screws in Children
Lateral humeral condyle fractures are the second most common elbow fractures in children. Displaced and rotated fractures require stabilization and reduction. Kirschner wires (K-wires) are most commonly used for fracture fixation. Here, the investigators introduce a new fixation method involving absorbable screws. The investigators aimed to determine if it is feasible to treat lateral humeral condyle fractures with absorbable screws by comparing the functional outcomes obtained using screw fixation vs. K-wire fixation.
Read the detailed description
Methods: Between May 2007 and September 2010, 86 participants (age, 1.6-13 years; average age, 6.7 years) were randomly divided into two groups. All participants had been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III. Closed reduction failed in all participants. Therefore, open reduction was performed under general anesthesia. One absorbable screw was used for fixation in the experimental group, while two 1.8-mm K-wires were used in the control group. At 4-6 weeks postoperatively, the participants' plaster casts were removed, and functional training was started.
- Conditions
- Humeral Fractures
- Being tested
- Absorbable screw group
- Keywords
- Absorbable screw, Internal fixation, Children
- Medical subject headings
- Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorbable screw groupProcedure or surgery
Open reduction was performed and one absorbable screw was used for fixation in the experimental group
| Study group | Role | What they receive |
|---|---|---|
| Absorbable screw group | Experimental | One absorbable screw was used for fixation in the experimental group Receives: Procedure: Absorbable screw group |
| K-wires group | No intervention | two 1.8-mm K-wires were used for the fixation in the control group. The K-wires were the most common used by the orthopaedic surgeon. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elbow Motion angle in degree
The orginal position was anatomy position （neutral position），Then，test the angle measured in degree of the elbow motion flexion, pronation and supination
Measured: 6 months after surgery.
Strength in Newton (N)
Compared to the normal hand, the investigators defined it normal to moderate loss and severe loss
Measured: 6 months after surgery.
stability
Compared to the normal hand, the investigators defined the elbow stability from normal to mild loss , moderate loss and severe loss
Measured: 6 months after surgery.
Pain
According to the level 0 ~ 10 to pain grading:0 to 3 for mild pain,4 to 6 for moderate pain,7 or more for severe pain
Measured: 6 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startMay 2007
- Primary completionSep 2010
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humeral FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuxi Su, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733666
- Sponsor's protocol ID
- Yuxi-2016-3-25
- Status last verified
- Apr 2016
- First submitted
- 25 Mar 2016
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Reduction and Internal Fixation of Lateral Humeral Condyle Fractures With Absorbable Screws in Children
- ClinicalTrials.gov ID
- NCT02733666
- Acronym / sponsor ID
- Yuxi-2016-3-25
- Conditions
- Humeral Fractures
- Keywords
- Absorbable screw, Internal fixation, Children
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Children's Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lateral humeral condyle fractures are the second most common elbow fractures in children. Displaced and rotated fractures require stabilization and reduction. Kirschner wires (K-wires) are most commonly used for fracture fixation. Here, the investigators introduce a new fixation method involving absorbable screws. The investigators aimed to determine if it is feasible to treat lateral humeral condyle fractures with absorbable screws by comparing the functional outcomes obtained using screw fixation vs. K-wire fixation.
Detailed description
Methods: Between May 2007 and September 2010, 86 participants (age, 1.6-13 years; average age, 6.7 years) were randomly divided into two groups. All participants had been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III. Closed reduction failed in all participants. Therefore, open reduction was performed under general anesthesia. One absorbable screw was used for fixation in the experimental group, while two 1.8-mm K-wires were used in the control group. At 4-6 weeks postoperatively, the participants' plaster casts were removed, and functional training was started.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absorbable screw group | Experimental | Procedure: Absorbable screw groupOne absorbable screw was used for fixation in the experimental group |
| K-wires group | No intervention | –two 1.8-mm K-wires were used for the fixation in the control group. The K-wires were the most common used by the orthopaedic surgeon. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All participants had been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III
Key exclusion criteria (1 listed)
- participants had not been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Absorbable screw groupOpen reduction was performed and one absorbable screw was used for fixation in the experimental group | Procedure or surgery | Absorbable screw group |
Primary outcome
Elbow Motion angle in degree
Time frame: 6 months after surgery.
The orginal position was anatomy position （neutral position），Then，test the angle measured in degree of the elbow motion flexion, pronation and supination
Strength in Newton (N)
Time frame: 6 months after surgery.
Compared to the normal hand, the investigators defined it normal to moderate loss and severe loss
stability
Time frame: 6 months after surgery.
Compared to the normal hand, the investigators defined the elbow stability from normal to mild loss , moderate loss and severe loss
Pain
Time frame: 6 months after surgery.
According to the level 0 ~ 10 to pain grading:0 to 3 for mild pain,4 to 6 for moderate pain,7 or more for severe pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Absorbable screw group in people with Humeral Fractures, run by Children's Hospital of Chongqing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elbow Motion angle in degree (time frame: 6 months after surgery.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2016.